ObesityNCT00111059
Primary Prevention Study: Study on Obesity, Cardiovascular and Psycho-Social Characteristics in the City of Merzig
An observational study of Obesity and Cardiovascular Disease, run by University Hospital, Saarland at 2 sites in Germany.
Trial summary
Cardiovascular risk factors and psycho-social characteristics will be determined in obese and non-obese patients in the setting of primary medical care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Cardiovascular Disease, Depression
- How many people
- 600 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2005to Apr 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or > 18
- BMI > 30 kg/m2
- Presenting to a participating primary care physician
Who cannot join
- Age < 18
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Klinik Innere Medizin III, Universitätsklinikum des Saarlandes
Homburg, Saarland, 66421
Ulrich Laufs, PD Dr, +49-(0)6841-162 ext. 3000, ulrich@laufs.com
Ulrich Laufs, PD Dr
- Recruiting
Praxisnetz Merzig
Merzig, Saarland, 66663
Volker Rettig-Ewen, Dr, +49-(0)6861-992902
About this study
Official title: Cross-Sectional Case-Control Study on Obesity, Cardiovascular and Psycho-Social Characteristics in the City of Merzig
Cardiovascular risk factors and psycho-social characteristics will be determined in obese and non-obese patients in the setting of primary medical care.
Read the detailed description
Cardiovascular risk factors and psycho-social characteristics will be determined using a questionnaire in primary care physician offices in the city of Merzig, Germany. We will recruit all people (age>18y) with a body-mass index (BMI) > 30 kg/m2 plus patients in the two following participating physician offices: Praxisnetz and Merzig. Cardiovascular risk will be assessed using the PROCAM (Munster Heart Study), ESC (European Society of Cardiology) and Framingham risk scores. Psycho-social factors will be recorded according to the methodology of the INTERHEART study.
- Conditions
- Obesity, Cardiovascular Disease, Depression, Stress
- Keywords
- obesity, cardiovascular disease, depression, stress
- Medical subject headings
- Obesity, Cardiovascular Diseases, Depression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2005 (estimated)
- Study startJan 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111059
- Sponsor's protocol ID
- 1
- Status last verified
- May 2005
- First submitted
- 16 May 2005
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Assmann G, Cullen P, Schulte H. Simple scoring scheme for calculating the risk of acute coronary events based on the 10-year follow-up of the prospective cardiovascular Munster (PROCAM) study. Circulation. 2002 Jan 22;105(3):310-5. doi: 10.1161/hc0302.102575.
PubMed 11804985Rosengren A, Hawken S, Ounpuu S, Sliwa K, Zubaid M, Almahmeed WA, Blackett KN, Sitthi-amorn C, Sato H, Yusuf S; INTERHEART investigators. Association of psychosocial risk factors with risk of acute myocardial infarction in 11119 cases and 13648 controls from 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):953-62. doi: 10.1016/S0140-6736(04)17019-0.
PubMed 15364186
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Sectional Case-Control Study on Obesity, Cardiovascular and Psycho-Social Characteristics in the City of Merzig
- ClinicalTrials.gov ID
- NCT00111059
- Acronym / sponsor ID
- 1
- Conditions
- Obesity, Cardiovascular Disease, Depression, Stress
- Keywords
- obesity, cardiovascular disease, depression, stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Apr 2006
- First posted
- 17 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiovascular risk factors and psycho-social characteristics will be determined in obese and non-obese patients in the setting of primary medical care.
Detailed description
Cardiovascular risk factors and psycho-social characteristics will be determined using a questionnaire in primary care physician offices in the city of Merzig, Germany. We will recruit all people (age>18y) with a body-mass index (BMI) > 30 kg/m2 plus patients in the two following participating physician offices: Praxisnetz and Merzig. Cardiovascular risk will be assessed using the PROCAM (Munster Heart Study), ESC (European Society of Cardiology) and Framingham risk scores. Psycho-social factors will be recorded according to the methodology of the INTERHEART study.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or > 18
- BMI > 30 kg/m2
- Presenting to a participating primary care physician
Key exclusion criteria (1 listed)
- Age < 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 11804985Assmann G, Cullen P, Schulte H. Simple scoring scheme for calculating the risk of acute coronary events based on the 10-year follow-up of the prospective cardiovascular Munster (PROCAM) study. Circulation. 2002 Jan 22;105(3):310-5. doi: 10.1161/hc0302.102575.
- Background: PubMed 15364186Rosengren A, Hawken S, Ounpuu S, Sliwa K, Zubaid M, Almahmeed WA, Blackett KN, Sitthi-amorn C, Sato H, Yusuf S; INTERHEART investigators. Association of psychosocial risk factors with risk of acute myocardial infarction in 11119 cases and 13648 controls from 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):953-62. doi: 10.1016/S0140-6736(04)17019-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klinik Innere Medizin III, Universitätsklinikum des Saarlandes
Homburg, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Cardiovascular Disease, run by University Hospital, Saarland at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00111059, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.